PbMedical Devices Auditor - QMS /b /ppApply locations: Italy | Posted: 30+ Days Ago | Job Requisition ID: JR0016196 /ppGreat that you're considering a career with BSI! /ppbPosition: /b Auditor Medical Devices (also known as Client Manager) /ppuLocation: /u Italy - field-based, with 70%-75% travel within EMEA /ppWe’re seeking talented individuals to join our medical device auditor team. The role involves traveling to various sites to assess quality management systems, supporting patient safety and regulatory compliance. Our audits cover standards such as ISO 9001 / ISO 13485 and schemes like MDSAP. We also assist with conformity assessments related to UKCA and CE marking. /ppbResponsibilities: /b /ppDuring the first six months as a Client Manager, you will: /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR standards /liliInitially observe audits, then progress to conducting them independently /li /ulpbPost-training, your typical weekly activities will include: /b /pulliConducting audits on-site, remotely, or in hybrid formats, independently or as part of a team /liliPreparing reports and coordinating with planning and delivery teams to manage clients and schedules /liliCompleting administrative tasks as needed /li /ulpbMinimum requirements for success: /b /polliAt least 4 years of hands-on experience in areas such as research and development, servicing, maintenance/testing, manufacturing, or production /liliExperience covering various medical devices, including: /li /olulliIVD (in vitro diagnostics) instrumentation and reagents /liliActive Implantable Medical Devices (e.g., Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device) /liliOrthopaedics (spinal implants, cements, cartilage, soft tissue repair) /liliWound and skin care products (dressings, foams, gels) /li /ulliAt least 2 years of experience working with quality management systems /liliCompleted a university or technical college degree (BSc, MSc, PhD) in a related STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics /lipbDo you believe the world deserves excellence? /b /ppHeadquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We partner with 86,000 companies in over 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family! /ppbDI Policy: /b /ppBSI is committed to workforce diversity, reflecting our clients and communities. We aim to create an inclusive environment where everyone can thrive, develop, and engage with our global organization while enjoying their work. /ppbLI-DNI /b /ppOur core behaviors: Client-centric, Agile, Collaborative. These principles guide how we operate at BSI, ensuring a positive workplace and successful business. /ppWe conduct face-to-face interviews where appropriate. If invited but more comfortable interviewing virtually, please discuss this with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr